As you may know, the FDA doesn’t tend to send, “how ya doing,” or, “how’s the family doing,” letters. Letters to companies that aren’t trying to get FDA approval for its products tend to be a whole lot more serious. In this case, the FDA warned Stemell and its CEO Peyman Taeidi, PhD about manufacturing and distributing unapproved products and failing to maintain adequate quality and safety standards. Other than that, no problem, right?

Apparently, during a March 2019 inspection of the company’s San Juan Capistrano, California, facility, the FDA found Stemell to be pushing the wrong buttons: belly buttons, or actually the things that were attached to belly buttons. According to the FDA, the company’s StemL UCB-Plus™ and StemL UCT-Plus™ products came from human umbilical cord blood and umbilical cords.

Why umbilical cords and cord blood? These are sources of stem cells. The FDA letter to Taeidi stated: “You describe your firm as ‘specializing in the harvesting and isolation of stem cells to manufacture and commercialize innovative products,’ and you distribute your products directly to physicians throughout the United States.”

They are unspecialized, so they cannot do specific functions in the body

They have the potential to become specialized cells, such as muscle cells, blood cells, and brain cells

Here is a TED-Ed primer on stem cells:

Think of stem cells as children who haven’t yet been forced to “become something” or generic building material that can be formed and shaped into what is needed. Thus, many are excited about the potential use of stem cells to change, fix, or renew different parts of the human body. But many of the possible uses are like dubstep: they may sound good but are far from fully developed and not yet approved for use.

The FDA letter continued by saying:

Information and records gathered at the time of and after the inspection, including product labeling and information on your website, https://stemell.com, reflect that your products, which your firm refers to as “regenerative cellular therapy,” are intended for clinical use in humans to treat a variety of diseases or conditions. You offer your products to medical professionals, clinics, and hospitals for use during “treatment procedure[s].” You specifically market your products to “[c]ombat inflammatory conditions such as arthritis” and more generally to “expedit[e] the healing process” and as an alternative to surgery. Stemell also encourages patients to consult with their doctors for more information about “the many additional potential uses” of your products.

Hmm, calling products “regenerative cellular therapy”? Offering these products to medical professionals, clinics, and hospitals to be used during “treatment procedures”? Claiming that these products can treat particular medical conditions? There is the saying that if it looks like a duck, swims like a duck, and quacks like a duck, then it probably is a duck. Do these Stemell products then sound like drugs to you?

The FDA thought so, and stated in the letter: “Therefore, based on your objective intent, your products are drugs as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)].”

If the Stemell products qualify as drugs, then they are drugs that have not been approved by the FDA. The FDA approval process is in place to protect consumers like you and me from fraudulent medications and other pieces of quack. Heck, without such FDA processes in place, kids could be setting up stem cell stands instead lemonade stands.

The FDA inspection also revealed “significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements.” For example, unless you saved your umbilical cord from birth or are still a newborn infant who inexplicably can already read, ordering umbilical cord-derived products from Stemell would mean getting stem cells other people. The question then is whether these cords were obtained ethically and are free of transmissible diseases. However, the FDA noted a lack of adequate procedures to ensure that appropriate sources were being used. Moreover, the FDA pointed out that the Stemell facility didn’t seem to have established safeguards to prevent the products from getting produced incorrectly, mixed up, or contaminated with bacteria, viruses, and other microorganisms. Yikes.

When you go to the Stemell website, a dialogue box appears entitled “For Medical Professional Viewing Only” that requires you to click “Agree” before you can view the rest of website. This dialogue box contains eight paragraphs of text and begins with the following statement: “Stemell, Inc. does not claim that therapy using StemL products cures or prevents any condition, disease or injury. All statements and opinions provided are for educational and informational purposes only, and we do not diagnose or provide medical or legal advice.” Further along in the dialogue box, the following statement appears: “This site was intended for education purposes only and strictly for use by medical professionals.” But once you get through the dialogue box and click “Agree”, you can then see a big button that says “Place an Order.” Would ordering a product then be only for educational purposes as well?

All of this emphasizes the importance of being very careful when considering any stem cell treatments. Remember that the stem cell industry is sort of like embryonic stem cells themselves, still very early in development. Many people are making claims about stem cell therapies that are just not backed by science yet. Just listen to what Charles E. Murry, MD, PhD, the William and Marilyn Conner Chair for the Institute for Stem Cell and Regenerative Medicine at the University of Washington, has to say about claims being made by stem cell clinics:

Before you undergo any type of stem cell treatment, ask if the FDA has reviewed and approved the proposed treatment. FDA review is necessary even if the treatment just involves your own stem cells. Getting your own stem cells placed inside of you is not the same as biting and eating your fingernails. There are real risks involved in any stem cell treatments such as allergic reactions, injury to wherever the stem cells are administered, and the possibility that the stem cells may move from where they were first placed, grow into inappropriate cell types, or develop into tumors. Check to make sure that the stem cell treatment being offered is on the FDA’s list of approved stem cell therapies.

Also, review the qualifications of the person giving you the stem cell therapy, and make sure that he or she is a real medical professional. Don’t get stem cell therapies from a medium, a naturopath, a sorcerer, a gardener, or anyone else who doesn’t have the proper experience and credentials.

The Stemell case also is a reminder that you should know where the stem cells came from and make sure that any company producing and handling the stem cells is following FDA regulations. We’ll see how Stemell responds to the FDA letter. The company has 15 working days from the date they received the letter to respond in writing. Will they have legitimate explanations for the FDA’s findings? Will they change their practices? In other words, how attached will they be to their current use of umbilical cords?